Biopharmaceutical Processing is a term that covers a broad area of applied science.  It refers to the use of biotechnology / genetic engineering approaches to generate modified cells that will express a new protein for use as a biotherapeutic.  In many cases, monoclonal antibodies are the proteins being produced, however this is certainly not always the case. It is a global, multi-billion dollar industry and one that Ireland is proud to be central to.  Upstream processing involves scaling up cells that are expressing your protein of interest to large densities whereby the protein can then subsequently be purified (downstream processing).  This scaling up often occurs in Bioreactors.  However, a lot of work has to be performed before one has their cell line of interest growing in a bioreactor.

For example, one must first have identified their gene of interest, which encodes the ultimate protein product.  This gene has to be inserted in to the expression system of choice in a manner that it will lead to the consistent, reproducible production of a functional protein product.  There are several aspects of construct generation and gene targeting that can facilitate expression of your gene in the chosen system.  Currently, the most favoured expression system being used are Chinese Hamster Ovary (CHO) cells.  These cells are capable of producing proteins that are folded and ‘decorated’ with post-translational modifications so that they will function in a human patient.  However, there are numerous expression systems you can choose to work with, depending on the protein you are expressing and the requirements for use.  Once a clone of your generated cell line that contains your gene of interest, and produces a satisfactory amount of protein product has been identified and purified, scale-up occurs whereby a bioreactor is used to increase cellular densities and product titre.  Downstream processing involves the purification of your protein of interest, which will make it more amenable for testing and the market.  This is a very regulated industry and one that is thriving in many different ways. There are advances in the field being made regularly, and it is certainly one to keep your eye on. I hope you will enjoy this module.

You can scroll down on this page for more information and access to course material.

A text book I would advise you to become familar with is one by Michael Butler entitled Cell Culture and Upstream Processing.  This is available in the DkIT library (position 660.63) and also an ebook version is available through the library website.  There are several other Bioprocessing textbooks in the vicinity of the above (e.g. Advanced Technologies in Biopharmaceutical Processing by Dutton and Scharer) that I also recommend you use to supplement lecture material.

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